A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes

NCT03115099 | Completed Phase 1 FDA Drug

• 2 other identifiers: 16433I8U-MC-DMBA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected. It will also investigate how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it. The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively

Secondary Outcomes (2)

• Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656

  Baseline up to 72 hours after each dose of study drug

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656

  Baseline up to 72 hours after each dose of study drug

Study Arms (6)

Placebo (Part A)

PLACEBO COMPARATOR

Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A

Drug: Placebo

LY3325656 (Part A)

EXPERIMENTAL

Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A

Drug: LY3325656

Placebo (Part B)

PLACEBO COMPARATOR

Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B

Drug: Placebo

LY3325656 (Part B)

EXPERIMENTAL

Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B

Drug: LY3325656

Liraglutide (Part B)

ACTIVE COMPARATOR

Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B

Drug: Liraglutide

LY3325656 + Sitagliptin (Part B)

EXPERIMENTAL

Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B

Drug: LY3325656; Drug: Sitagliptin

Interventions

LY3325656 DRUG

Administered orally

LY3325656 (Part A); LY3325656 (Part B); LY3325656 + Sitagliptin (Part B)

Placebo DRUG

Administered orally

Placebo (Part A); Placebo (Part B)

Liraglutide DRUG

Administered subcutaneously

Liraglutide (Part B)

Sitagliptin DRUG

Administered orally

LY3325656 + Sitagliptin (Part B)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all participants:
• Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
• Have a screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
• Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study
• For participants with Type 2 Diabetes Mellitus:
• Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
• Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
• Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)

You may not qualify if:

• For all participants:
• Are currently participating in another clinical study or completed one in the last 30 days
• Are allergic to LY3325656 or other related drugs
• Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
• Have electrocardiogram (ECG) readings that are not suitable for the study
• Are infected with hepatitis B
• Are infected with human immunodeficiency virus (HIV)
• Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
• Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
• Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
• For participants with Type 2 Diabetes Mellitus:
• Have had heart disease or stroke within 6 months before entering the study
• Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
• Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
• Have used insulin to control diabetes in the last 6 months

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

Singapore, 117597, Singapore

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Singapore, Singapore

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide; Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 14, 2017
• Study Start: May 31, 2017
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

SG (2)